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"ProductSpec": [ { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108106002190c503", "ProductName": "GLDH3", "ProductLongName": "GLDH Gen.3", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF00000004ED660E", "DocumentOriginID": "FF00000004C0190E", "MaterialNumbers": [ "08106002190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

α‑ketoglutarate + NADH + NH4+

GLDH

glutamate + NAD+ + H2O

The decrease in NADH is directly proportional to the GLDH activity.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 1 U/L (0.0167 µkat/L)

Limit of Detection

= 1 U/L (0.0167 µkat/L)

Limit of Quantitation

= 3 U/L (0.0501 µkat/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity glutamate dehydrogenase samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

U/L

Adults
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males
Females

up to 6.4 U/L
up to 4.8 U/L

a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

Consensus values for adults
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males
Females

up to 7.0 U/L
up to 5.0 U/L

µkat/L*

Adults
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males
Females

up to 0.11 µkat/L
up to 0.08 µkat/L

a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

Consensus values for adults
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males
Females

up to 0.12 µkat/L
up to 0.08 µkat/L

*calculated by unit conversion factor

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 50 (approximate hemoglobin concentration: 31.0 µmol/L or 50 mg/dL). Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 100. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Pyruvate: No significant interference from pyruvate up to a concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.
Exceptions: Physiological plasma concentrations of sulfasalazine or sulfapyridine may lead to false results. Temozolomide at therapeutic concentrations may lead to erroneous results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08106002190

GLDH Gen.3 (3 x 160 tests)

System‑ID 2061 001

cobas c 303, cobas c 503

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05117003190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

GLDH3: ACN 20610

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

78

R3

17 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

10.8 µL

Decreased

2.2 µL

Increased

10.8 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

3 week

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- after 7 days on‑board
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

23.2

0.344

1.5

PCCC2b)

37.1

0.346

0.9

Human serum 1

5.37

0.223

4.1

Human serum 2

7.51

0.321

4.3

Human serum 3

23.0

0.341

1.5

Human serum 4

41.6

0.857

2.1

Human serum 5

71.5

0.658

0.9

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

23.2

0.377

1.6

PCCC2

FREFPreciControl ClinChem Multi 2

37.2

0.534

1.4

Human serum 1

5.37

0.356

6.6

Human serum 2

7.43

0.428

5.8

Human serum 3

23.0

0.362

1.6

Human serum 4

41.6

0.926

2.2

Human serum 5

71.5

1.25

1.7

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

Method comparison

Glutamate dehydrogenase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 76

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.993x - 0.0893 U/L

y = 0.975x - 0.0252 U/L

τ = 0.861

r = 0.999

The sample activities were between 1.40 and 76.7 U/L.

Glutamate dehydrogenase values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 98

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.028x - 0.466 U/L

y = 1.022x - 0.378 U/L

τ = 0.971

r = 0.999

The sample activities were between 1.60 and 78.7 U/L.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.
,
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Bottle R1:
Triethanolamine buffer: 60 mmol/L, pH 8.0; EDTA: 3.1 mmol/L; ammonium acetate: 124 mmol/L; stabilizers; preservative
Bottle R1a:
ADP: ≥ 1.36 mmol/L; NADH (yeast): 0.27 mmol/L; LDH (rabbit muscle): ≥ 45 µkat/L

R3

Triethanolamine buffer: 8.6 mmol/L, pH 7.9; α‑ketoglutarate: 48 mmol/L; stabilizers; preservative

R1 has to be filled into position B after reagent preparation (see Reagent handling section). R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 3 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C
7 days at 2‑8 °C
4 weeks at (−15)‑(−25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108106002190c503", "ProductName": "GLDH3", "ProductLongName": "GLDH Gen.3", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000039F330E", "DocumentOriginID": "FF000000039F330E", "MaterialNumbers": [ "08106002190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

α‑ketoglutarate + NADH + NH4+

GLDH

glutamate + NAD+ + H2O

The decrease in NADH is directly proportional to the GLDH activity.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 1 U/L (0.0167 µkat/L)

Limit of Detection

= 1 U/L (0.0167 µkat/L)

Limit of Quantitation

= 3 U/L (0.0501 µkat/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity glutamate dehydrogenase samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

U/L

Adults
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males
Females

up to 6.4 U/L
up to 4.8 U/L

a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

Consensus values for adults
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males
Females

up to 7.0 U/L
up to 5.0 U/L

µkat/L*

Adults
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males
Females

up to 0.11 µkat/L
up to 0.08 µkat/L

a) Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

Consensus values for adults
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males
Females

up to 0.12 µkat/L
up to 0.08 µkat/L

*calculated by unit conversion factor

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 50 (approximate hemoglobin concentration: 31.0 µmol/L or 50 mg/dL). Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 100. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Pyruvate: No significant interference from pyruvate up to a concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.
Exceptions: Physiological plasma concentrations of sulfasalazine or sulfapyridine may lead to false results. Temozolomide at therapeutic concentrations may lead to erroneous results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08106002 190

GLDH Gen.3 (3 x 160 tests)

System‑ID 2061 001

cobas c 503

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

GLDH3: ACN 20610

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/340 nm

Reagent pipetting

Diluent (H2O)

R1

78

R3

17 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

10.8 µL

Decreased

2.2 µL

Increased

10.8 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

3 week

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- after 7 days on‑board
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

23.2

0.344

1.5

PCCC2b)

37.1

0.346

0.9

Human serum 1

5.37

0.223

4.1

Human serum 2

7.51

0.321

4.3

Human serum 3

23.0

0.341

1.5

Human serum 4

41.6

0.857

2.1

Human serum 5

71.5

0.658

0.9

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

23.2

0.377

1.6

PCCC2

FREFPreciControl ClinChem Multi 2

37.2

0.534

1.4

Human serum 1

5.37

0.356

6.6

Human serum 2

7.43

0.428

5.8

Human serum 3

23.0

0.362

1.6

Human serum 4

41.6

0.926

2.2

Human serum 5

71.5

1.25

1.7

Method comparison

Glutamate dehydrogenase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 76

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.993x - 0.0893 U/L

y = 0.975x - 0.0252 U/L

τ = 0.861

r = 0.999

The sample activities were between 1.40 and 76.7 U/L.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.
,
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Bottle R1:
Triethanolamine buffer: 60 mmol/L, pH 8.0; EDTA: 3.1 mmol/L; ammonium acetate: 124 mmol/L; stabilizers; preservative
Bottle R1a:
ADP: ≥ 1.36 mmol/L; NADH (yeast): 0.27 mmol/L; LDH (rabbit muscle): ≥ 45 µkat/L

R3

Triethanolamine buffer: 8.6 mmol/L, pH 7.9; α‑ketoglutarate: 48 mmol/L; stabilizers; preservative

R1 has to be filled into position B after reagent preparation (see Reagent handling section). R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 3 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C
7 days at 2‑8 °C
4 weeks at (−15)‑(−25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0105975956190c701", "ProductName": "GLDH3", "ProductLongName": "GLDH Gen.3", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF000000047B880E", "DocumentOriginID": "FF0000000045090E", "MaterialNumbers": [ "05975956190" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

GLDH

α‑ketoglutarate + NADH + NH4+

glutamate + NAD+ + H2O

The decrease in NADH is directly proportional to the GLDH activity.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Lower detection limit of the test:

1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 1 U/L) will not be flagged by the instrument.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Adults

LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males
Females

up to 6.4 U/L
up to 4.8 U/L

(up to 0.11 µkat/L)
(up to 0.08 µkat/L)

Consensus values for adults

LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males
Females

up to 7.0 U/L
up to 5.0 U/L

(up to 0.12 µkat/L)
(up to 0.08 µkat/L)

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

a)  Calculated with a temperature conversion factor of 1.61 (25→37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L (0.1 µkat/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 50 (approximate hemoglobin concentration: 31.0 µmol/L or 50 mg/dL). Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 40. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Pyruvate: No significant interference up to a pyruvate concentration of 300 μmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Exceptions: Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results. Temozolomide at therapeutic concentrations may lead to erroneous results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05975956 190

GLDH Gen.3 (3 x 120 tests)

System‑ID 03 6789 1

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5  mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5  mL)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

GLDH3: ACN 8588

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Transfer content of bottle R1 into the bottle R1a. Close the bottle and mix gently until the solid components are dissolved. Fill the mixture into cobas c pack position B.

R3 is ready for use.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 701/702 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 24‑38

Wavelength (sub/main)

700/340 nm

Reaction direction

Decrease

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

90 µL

R3

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

12.5 µL

Decreased

2.5 µL

Increased

25 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

1 week

On‑board on the Reagent Manager:

0 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

23.1 (0.386)

0.2 (0.003)

1.0

Precipath U

34.6 (0.578)

0.2 (0.003)

0.5

Human serum A

6.02 (0.101)

0.27 (0.005)

4.5

Human serum B

1.84 (0.031)

0.25 (0.004)

13.7

Human serum C

67.3 (1.12)

0.4 (0.01)

0.6

Intermediate precision

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

23.8 (0.397)

0.2 (0.004)

1.0

Precipath U

32.7 (0.546)

0.3 (0.004)

0.8

Human serum 3

1.04 (0.017)

0.21 (0.003)

20.0

Human serum 4

21.3 (0.356)

0.3 (0.005)

1.5

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

Method comparison

Glutamate dehydrogenase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 94

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.993x - 0.469 U/L

y = 0.991x - 0.498 U/L

τ = 0.950

r = 0.999

The sample activities were between 1.40 and 77.9 U/L (0.023 and 1.30 µkat/L).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.
,
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

(cobas c pack position B)
(Bottle R1)
Triethanolamine buffer: 60 mmol/L, pH 8.0; EDTA: 3.1 mmol/L; ammonium acetate: 124 mmol/L; stabilizers; preservative
(Bottle R1a)
ADP: ≥ 1.36 mmol/L; NADH (yeast): 0.27 mmol/L; LDH (rabbit muscle): ≥ 45 µkat/L

R3

(cobas c pack position C)

Triethanolamine buffer: 8.6 mmol/L, pH 7.9; α‑ketoglutarate: 48 mmol/L; stabilizers; preservative

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum.

Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C
7 days at 2‑8 °C
4 weeks at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0111929992216COIN", "ProductName": "GLDH3", "ProductLongName": "GLDH Gen.3", "Language": "en", "DocumentVersion": "6", "DocumentObjectID": "FF0000000485BD0E", "DocumentOriginID": "FF00000000A4C90E", "MaterialNumbers": [ "11929992216" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of the catalytic activity of GLDH (EC 1.4.1.3; glutamate dehydrogenase) in human serum and plasma on COBAS INTEGRA systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

UV test according to a standardized method

The GLDH enzyme catalyzes this NADH-dependent reaction; the equilibrium is on the side of glutamate and NAD.

α-ketoglutarate + NADH + NH4+

GLDH

glutamate + NAD+ + H2O

The decrease in NADH is directly proportional to the GLDH activity.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:5 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 5.

Lower limits of measurement

Lower detection limit of the test:
1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Adults
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.

Males

up to 6.4 U/L (0.11 µkat/L)*

Females

up to 4.8 U/L (0.08 µkat/L)*

*Calculated with a temperature conversion factor of 1.61 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

Consensus values for adults
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Males

up to 7.0 U/L (0.12 µkat/L)

Females

up to 5.0 U/L (0.08 µkat/L)

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre-Analytical Considerations”, Cat. Nos. 11322524 001 (English), 04347234 001 (German).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value.

Serum, plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 22 for conjugated bilirubin and 54 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 376 µmol/L or 22 mg/dL; approximate unconjugated bilirubin concentration: 923 µmol/L or 54 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 10 (approximate hemoglobin concentration: 6 µmol/L or 10 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 180. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.
Exceptions : Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results. Temozolomide at therapeutic concentrations may lead to erroneous results.

Pyruvate: No significant interference up to a pyruvate concentration of 300 µmol/L (26 mg/dL).

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on COBAS INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

Orderinformation_INT

Order information

Analyzer(s) on which cobas c pack(s) can be used

11929992 216

GLDH Gen.3 (4 × 100 tests)

System-ID 07 6789 1

COBAS INTEGRA 400 plus
COBAS INTEGRA 800

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 × 3 mL)

System-ID 07 3718 6

12149435 122

Precinorm U plus (10 × 3 mL)

System-ID 07 7999 7

12149443 122

Precipath U plus (10 × 3 mL)

System-ID 07 8000 6

10171743 122

Precinorm U (20 × 5 mL)

System-ID 07 7997 0

10171735 122

Precinorm U (4 × 5 mL)

System-ID 07 7997 0

10171778 122

Precipath U (20 × 5 mL)

System-ID 07 7998 9

10171760 122

Precipath U (4 × 5 mL)

System-ID 07 7998 9

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

20756350 322

NaCl Diluent 9 % (6 × 22 mL)

System-ID 07 5635 0

04593138 190

cobas c pack MULTI

on request

Open/Close tool

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Test GLDH3, test ID 0‑189

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent preparation and cobas c pack MULTI assembly

Reagent handling

R1: Connect one bottle 1 to one bottle 1a using the enclosed adapter and dissolve the lyophilizate completely in the buffer.

SR: Ready for use.

Labeling the cobas c pack MULTI

Turn the barcode labeled side of a new cobas c pack MULTI toward you. Affix the supplied GLDH3 barcode label directly over the existing barcode label.

Filling the cobas c pack MULTI

  1. Turn the cobas c pack MULTI toward you as shown above.

  2. Position A of the cobas c pack is now in the center, position B on the left side, position C on the right side of the cobas c pack.

  3. Unscrew the screw cap of the bottle in position A in the center of the cobas c pack MULTI using the Open/Close tool.

  4. Pour the content of bottle 1 (19 mL) into the opened bottle of the cobas c pack (position A).

  5. Close the bottle tightly using the Open/Close tool.

  6. Unscrew the screw cap of the bottle in position C on the right side of the cobas c pack MULTI using the Open/Close tool.

  7. Pour the content of bottle 2 (5 mL) into the opened bottle of the cobas c pack (position C).

  8. Close the bottle tightly using the Open/Close tool.

  9. Leave position B empty.

The GLDH3 cobas c pack is now ready for use.

Note

Use only the cobas c pack MULTI. Always use a newcobas cpack MULTI when preparing fresh reagent. Never reuse accessories designed for single use, as this may result in reagent contamination and could affect test results. If thecobas c pack MULTI bottles are not filled correctly, this may result in faulty reagent pipetting and could cause erroneous results.

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

COBAS INTEGRA 400 plus test definition

Measuring mode

Absorbance

Abs. calculation mode

Kinetic

Reaction mode

R1-S-SR

Reaction direction

Decrease

Wavelength A/B

340/409 nm

Calc. first/last

43/65

Unit

U/L

Pipetting parameters

Diluent (H2O)

R1

85 µL

Sample

17.5 µL

5 µL

SR

20 µL

Total volume

127.5 µL

COBAS INTEGRA 800 test definition

Measuring mode

Absorbance

Abs. calculation mode

Kinetic

Reaction mode

R1-S-SR

Reaction direction

Decrease

Wavelength A/B

340/409 nm

Calc. first/last

60/98

Unit

U/L

Pipetting parameters

Diluent (H2O)

R1

85 µL

Sample

17.5 µL

5 µL

SR

20 µL

Total volume

127.5 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C

See expiration date on cobas c pack label

COBAS INTEGRA 400 plus system

On-board in use at 10‑15 °C

3 weeks

COBAS INTEGRA 800 system

On-board in use at 8 °C

3 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrator

Calibrator f.a.s.

Use deionized water as zero calibrator.

Calibration mode

Linear regression

Calibration replicate

Duplicate recommended

Calibration interval

Each lot and every 7 days and as required following quality control procedures.

Traceability: This method has been standardized against the Roche reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

Serum, plasma

Repeatability

Level 1

Level 2

Mean

22.8 U/L
(0.380 µkat/L)

22.3 U/L
(0.372 µkat/L)

CV

0.8 %

0.4 %

Intermediate precision

Level 1

Level 2

Mean

22.7 U/L
(0.378 µkat/L)

22.0 U/L
(0.367 µkat/L)

CV

1.2 %

1.0 %

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

GLDH values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer with the application GLDH3 (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Roche/Hitachi 917 analyzer

Sample size (n) = 60

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.98x + 0.25 U/L

y = 0.98x + 0.31 U/L

τ = 0.9711

r = 0.9989

SD (md 95) = 1.08

Sy.x = 0.44

The sample activities were between 0.6 and 65.5 U/L (0.01 and 1.09 µkat/L).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.
,
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver-specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society of Clinical Chemistry (DGKC) and optimized for performance and stability.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Triethanolamine buffer: 60 mmol/L, pH 8.0; EDTA: 3.1 mmol/L; ammonium acetate: 124 mmol/L; ADP: ≥ 1.36 mmol/L; NADH (yeast): 0.27 mmol/L; LDH (rabbit muscle): ≥ 45 µkat/L; stabilizers; preservative

SR

Triethanolamine buffer: 8.6 mmol/L, pH 7.9; α‑ketoglutarate: 48 mmol/L; stabilizers; preservative

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Reference range

Precinorm U, Precinorm U plus or PreciControl ClinChem Multi 1

Pathological range

Precipath U, Precipath U plus or PreciControl ClinChem Multi 2

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum: Collect serum using standard sampling tubes.
Plasma: Heparin (Li‑, Na‑, NH4+‑) or EDTA (K2‑, K3‑) plasma.

EDTA plasma values are about 8 % lower than serum values.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C

7 days at 2‑4 °C

4 weeks at (‑15)‑(‑25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0111929992216c501", "ProductName": "GLDH3", "ProductLongName": "GLDH Gen.3", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF0000000485C40E", "DocumentOriginID": "FF000000003A190E", "MaterialNumbers": [ "11929992216" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of glutamate dehydrogenase (GLDH) in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

UV test according to a standardized method.

The GLDH enzyme catalyzes this NADH‑dependent reaction; the equilibrium is on the side of glutamate and NAD.

GLDH

α‑ketoglutarate + NADH + NH4+

glutamate + NAD+ + H2O

The decrease in NADH is directly proportional to the GLDH activity.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

1‑80 U/L (0.0167‑1.34 µkat/L)

Determine samples having higher activities via the rerun function. For samples with higher activities, the rerun function decreases the sample volume by a factor of 5. The results are automatically multiplied by this factor.

Lower limits of measurement

Lower detection limit of the test:

1 U/L (0.0167 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Adults

LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFWallnöfer H, Schmidt E, Schmidt FW, eds. Synopsis der Leberkrankheiten. Stuttgart: Georg Thieme Verlag 1974.
,a)

Males

up to 6.4 U/L

(up to 0.11 µkat/L)

Females

up to 4.8 U/L

(up to 0.08 µkat/L)

Consensus values for adults

LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Males

up to 7.0 U/L

(up to 0.12 µkat/L)

Females

up to 5.0 U/L

(up to 0.08 µkat/L)

Reference ranges for children are given in the brochure “Reference Ranges for Adults and Children. Pre‑Analytical Considerations”. Heil W, Koberstein R, Zawta B (published by Roche Diagnostics GmbH, 2004).

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

a) Calculated with a temperature conversion factor of 1.61 (25 -> 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a glutamate dehydrogenase activity of 6 U/L (0.1 µkat/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 50 (approximate hemoglobin concentration: 31.0 µmol/L or 50 mg/dL). Contamination with erythrocytes will elevate results, because the analyte level in erythrocytes is higher than in normal sera. The level of interference may be variable depending on the content of analyte in the lysed erythrocytes.

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 100. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Pyruvate: No significant interference from pyruvate up to a concentration of 300 µmol/L (26 mg/dL).

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.
.

Exceptions: Temozolomide at therapeutic concentrations may lead to erroneous results.

Physiological plasma concentrations of Sulfasalazine or Sulfapyridine may lead to false results.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

11929992 216

GLDH Gen.3 (4 x 100 tests)

System‑ID  07 6789 1

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

04593138 190

cobas c pack MULTI

On request

Open/Close tool

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

GLDH3: ACN 588

For cobas c 502 analyzer:

GLDH3: ACN 8588

", "Language": "en" }, { "Name": "Handling", "Value": "", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 311 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 13‑31

Wavelength (sub/main)

700/340 nm

Reaction direction

Decrease

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

90 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

12.5 µL

Decreased

2.5 µL

Increased

12.5 µL

cobas c 501 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 19‑46

Wavelength (sub/main)

700/340 nm

Reaction direction

Decrease

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

90 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

12.5 µL

Decreased

2.5 µL

Increased

12.5 µL

cobas c 502 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 19‑46

Wavelength (sub/main)

700/340 nm

Reaction direction

Decrease

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

90 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

12.5 µL

Decreased

2.5 µL

Increased

25 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

GLDH3

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

3 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after 7 days on board
- after lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against the Roche system reagent using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

20.8 (0.347)

0.2 (0.003)

0.8

Precipath U

30.4 (0.508)

0.1 (0.002)

0.5

Human serum 1

4.78 (0.017)

0.14 (0.002)

2.9

Human serum 2

10.1 (0.169)

0.2 (0.003)

2.0

Intermediate precision

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

23.8 (0.397)

0.2 (0.004)

1.0

Precipath U

32.7 (0.546)

0.3 (0.004)

0.8

Human serum 3

1.04 (0.017)

0.21 (0.003)

20.0

Human serum 4

21.3 (0.356)

0.3 (0.005)

1.5

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Glutamate dehydrogenase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

Sample size (n) = 59

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.982x + 0.296 U/L

y = 0.995x + 0.254 U/L

τ = 0.902

r = 0.998

The sample activities were between 1.00 and 70.0 U/L (0.017 and 1.17 µkat/L).

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFGreiling H, Gressner AM, eds. Lehrbuch der Klinischen Chemie und Pathobiochemie, 3rd ed. Stuttgart/New York: Schattauer Verlag 1995.
,
LREFChemnitz G, Schmidt E, Schmidt FW, et al.Diagnostische und prognostische Bedeutung massiv erhöhter Glutamat-Dehydrogenase-Aktivität im Serum. Dtsch Med Wschr 1984;109:1789-1793.
,
LREFDeutsche Gesellschaft für Klinische Chemie: Empfehlungen der Deutschen Gesellschaft für Klinische Chemie (DGKC). J Clin Chem Clin Biochem 1972;10:182-193.

GLDH is a largely liver‑specific enzyme found exclusively in the mitochondria and located predominantly within the liver cell acinus. GLDH activity in other organs such as the kidneys, pancreas, heart, brain and intestines is negligible. Determination of GLDH activity is performed to diagnose liver disorders, and in particular to assess the severity of damage to individual cells. Necrotizing liver damage such as acute hepatic dystrophy, necrotizing hepatitis, multiple liver metastases and obstructive jaundice are accompanied by elevated GLDH activities in serum.

In 1972, the German Society for Clinical Chemistry (DGKC) recommended the optimized standard method for determination of GLDH with optimized substrate concentration, NADH excess, and activation of GLDH by addition of ADP. The method described here is derived from the formulation recommended by the German Society for Clinical Chemistry (DGKC) and optimized for performance and stability.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Triethanolamine buffer: 60 mmol/L, pH 8.0; EDTA: 3.1 mmol/L; ammonium acetate: 124 mmol/L; ADP: ≥ 1.36 mmol/L; NADH (yeast): 0.27 mmol/L; LDH (rabbit muscle): ≥ 45 µkat/L; stabilizers; preservative

R2

Triethanolamine buffer: 8.6 mmol/L, pH 7.9; α‑ketoglutarate: 48 mmol/L; stabilizers; preservative

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum

Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFGuder WG, Narayanan S, Wisser H, et al. List of Analytes; Preanalytical Variables. Brochure in: Samples: From the Patient to the Laboratory. Darmstadt: GIT-Verlag 1996.

7 days at 15‑25 °C
7 days at 2‑8 °C
4 weeks at (-15)‑(-25) °C

", "Language": "en" } ] } } ] }

GLDH3

GLDH Gen.3

IVD For in vitro diagnostic use.
GLDH3

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

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